Be a Part of a Pioneering Medical Device Company: Regulatory Affairs Specialist
Do you thrive in a fast-paced environment where your expertise ensures the safety of millions?
For a leading innovator in the medical device industry, that's on a mission to improve patient lives with cutting-edge technology. We're searching for a passionate Regulatory Affairs Specialist to join a dedicated team and play a vital role in bringing our groundbreaking devices to market.
In this role, you'll be the guardian of compliance, ensuring our high-risk medical devices meet the most rigorous international standards. You'll navigate the complex world of regulations, collaborating closely with cross-functional teams like R&D, Quality Assurance, and Marketing.
Here's what a typical day might look like:
- Spearhead country registrations in the EU and beyond, ensuring flawless compliance with international laws.
- Prepare and maintain comprehensive documentation for regulatory submissions, including MDR technical files and FDA 510k applications.
- Track, control, and advise on compliance for submissions, interacting with regulatory authorities as needed.
- Support new and modified product development projects by integrating regulatory considerations from the outset.
- Review marketing materials and labeling for adherence to regulations.
- Handle product complaints and contribute to robust vigilance reporting.
- Participate in product and process risk management activities.
- Compile and maintain essential post-market documents like PMS, PMCF, SSCP, and PSUR reports.
Requirements:
- A Bachelor's degree (or equivalent) in a relevant field.
- 6+ years of experience in a similar role within the medical device industry.
- In-depth knowledge of European and US medical device regulations (e.g.,EU-MDR, ISO 13485:2016, FDA/QSR regulations).
- Expertise in writing and reviewing regulatory submissions for high-risk medical devices.
- Strong project management and interpersonal skills with a talent for clear communication – internally and externally.
- Impeccable written and verbal communication skills in English.
Send your CV to Aimee at a.brenner@panda-int.com or call +31202044502 to learn more about this exciting opportunity!